365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL

Recall Number: D-0631-2022

Firm: Je Dois Lavoir LLC

Classification: Class I

Status: Terminated

Report Date: 20220223

Initiation Date: 20210802

Termination Date: 20230502

Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.

365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL